Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment

June 29, 2017 updated by: IC-IT Sciences Inc.
Prospective, randomized crossover study to compare the NFT sleep patches to sham device to assess sleep via home sleep testing device in the home environment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alameda, California, United States, 94501
        • Recruiting
        • California Center for Sleep Disorders
        • Contact:
        • Principal Investigator:
          • Jerrold Kram, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • capacity to provide informed consent
  • BMI <30
  • between 30 and 65 years old
  • in overall good health as determined by history and physical assessment subjects pre-screened to ensure they are drug free
  • work a typical day job/work week.
  • not traveled > 3 time zones in the last month
  • typical bedtime between 9-12 PM
  • estimated on average 6 hours per night
  • negative urine drug screen
  • have self-reported unrefreshing sleep for the past month
  • agree to limit alcohol use to no more than two drinks a night during the testing period and four hours prior to bedtime
  • agree to limit caffeine consumption to four hours prior to bedtime
  • ≤ 2 on the depression scale
  • ≤ 3 on the anxiety scale

Exclusion Criteria:

  • pregnant or nursing a child
  • self-induced short sleep habits (<6 hours per night)
  • unstable medical conditions as determined by the clinician
  • current sleep disorder (sleep apnea AHI/REI<5, restless legs, periodic limb movements, narcolepsy)
  • self-reported sleep latency of >30 minutes or early (3-4 AM) awakenings on a regular basis
  • contact dermatitis to adhesives
  • excluded Medications: over the counter sleep aids, prescribed sleep aids, central nervous system stimulants, antidepressants, sedating antihistamines, over the counter decongestants and opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham Natural Frequency Patch
Other: Natural Frequency Patch
Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights
ACTIVE_COMPARATOR: Active Natural Frequency Patch
Other: Natural Frequency Patch
Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: three nights
Assess sleep via home EEG recording
three nights

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IC-IT Sciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2017

Primary Completion (ANTICIPATED)

December 31, 2017

Study Completion (ANTICIPATED)

December 31, 2017

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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